You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014-2015 calendar years.
In today’s day and age, it is a widely accepted and understood requirement that conducting clinical research for investigational new drugs and devices in the United States means that you will be responsible for following the FDA regulations. The terms, “according to the regulations, “or “according to the regs,” are used commonly, as we all have grown accustomed to these seemingly intuitive laws that govern the practice of clinical research. However, not too long ago, the regulations we freely refer to now did not exist. It wasn’t until after the 1979 Belmont Report, that FDA and the Department of Health and Human Services formally revised regulations for human subject protections by creating Title 21 - Food and Drugs.
Topics: History of Clinical Research Timeline, FDA Regulations, Code of Federal Regulations (CFR) Title 21
